Applicator device for a medical device accessory

Abstract

An applicator for fitting a tubular cover over a distal end of a shaft of a medical device comprising a flexible sheet 30 which is deformable into an arcuate shape, wherein the applicator is insertable into a bore defined by a tubular cover 10 such that the applicator defines a guide channel configured to receive a distal end of a shaft of a medical device (50; figure 9). The applicator may comprise an elongate element 32 alongside a plurality of fingers extending laterally from the element. The fingers may comprise a proximal region adjacent to the elongate strip alongside a distal portion wherein the distal portion is foldable to define a guide channel. Other embodiments of the applicator may be formed into a H shape (60; figure 14a) comprising a plurality of elongate elements (62; figure 14a). Other embodiments of the applicator may be formed int a substantially U shape (70; figure 15a) having a plurality of elongate elements (72; figure 15a).

Description

Field The present disclosure relates to an applicator device to facilitate fitting an accessory onto the distal end of a shaft of a medical device. Background US2019 / 0183328 describes a cover for the shaft of a medical device, in particular for fitting over the distal tip of an endoscope. The cover is a tubular member with proximal and distal ends and inner and outer circumferential surfaces. A plurality of projecting elements is provided on the outer surface of the cover which in use extend radially outwardly. These can pull back or flatten folds of body tissue to aid inspection of a body cavity for carrying out other medical procedures with the medical scope. However, it can be difficult and time consuming to fit such accessories to the distal end of a shaft of a medical device. There is therefore a need to find a way to fit such an accessory more easily and quickly so that procedures can be carried out more efficiently by health care professionals. Summary The present disclosure provides an applicator device for fitting a tubular cover over a distal end of a shaft of a medical device as set out in claim 1. The present disclosure also provides a method for fitting a tubular cover to a shaft of a medical device using an applicator as set out in claim 12. The present disclosure further provides a holder for a tubular cover for fitting over a distal end of a shaft of a medical device as set out in claim 15. Brief Description of the Drawings Figure 1 is a plan view of a first embodiment of an applicator in accordance with the present disclosure; Figure 2 is a perspective view of the applicator of Figure 1; Figure 3 is a perspective view of the applicator of Figure 1 in its folded configuration ready for use; Figure 4 is a plan view of the folded applicator of Figure 3; Figure 5 is a perspective view of a typical accessory for fitting onto a shaft of a medical device; Figure 6 is a side view of the accessory of Figure 5 with the applicator of Figures 1 - 4 in its folded configuration and applied to the accessory; Figure 7 is a perspective view of the accessory and applicator of Figure 6; Figure 8 is a plan view of the accessory and applicator of Figure 6; Figures 9-13 each show a perspective view and a side view of an accessory and applicator, and show a method for fitting the accessory to a shaft of a medical device; Figure 14a shows a plan and a perspective view of a second embodiment of an applicator; Figure 14b shows the applicator of Figure 14a folded and inserted into an accessory; Figure 15a shows a plan and a perspective view of a third embodiment of an applicator; Figure 15b shows the applicator of Figure 15a folded and inserted into an accessory; Figure 16a shows a plan and a perspective view of a fourth embodiment of an applicator; Figure 16b shows the applicator of Figure 16a folded and inserted into an accessory; Figure 17a shows a plan view of a fifth embodiment of an applicator; Figure 17b shows a perspective view of the applicator of Figure 17a when folded and ready for use; Figures 17c and d show the applicator of Figures 17a and b in use; Figure 18 shows plan, perspective, side and cross-sectional views of an example of a container suitable for storing an accessory; Figure 19 shows plan, perspective, side and cross-sectional views of the container of Figure 18 with an accessory in place; Figure 20 shows plan, perspective, side and cross-sectional views of the container and accessory of Figure 19 during insertion of a shaft of a medical device; Figure 21 illustrates removal of the shaft and accessory from the container; and Figure 22 shows plan, perspective, side and cross-sectional views of the shaft and accessory when fully removed from the container. Detailed Description A typical accessory 10 for fitting to a shaft of a medical device is shown in Figure 5. The accessory 10 comprises a generally cylindrical body 12 with a first end 14, a second end 16 and defining an internal bore 18. A plurality of radially protruding arms 20 is formed on the external surface of the body 12. The body 12 may have axially extending ribs 22 on the interior and exterior surfaces. In use, the cylindrical body 12 forms a friction fit around the distal end of a shaft 50 of a medical device. An applicator 30 in accordance with the present disclosure essentially comprises a thin flexible sheet which can be folded and partially inserted into the bore 18 of the cylindrical body 12 of the accessory 10 to form a guide sleeve to facilitate insertion of the shaft of the medical device into the accessory 10. The applicator 30 serves to support and stiffen the body 12 during insertion of the shaft 50, to prevent the body 12 distorting or becoming crumpled up. Once the accessory 10 has been fitted to the shaft 50 the applicator 30 is removed, leaving the accessory 10 in position on the shaft 50. A first embodiment of an applicator 30 is shown in Figures 1 - 4. The applicator 30 is formed from a thin flexible sheet. For example, it may be formed of a plastic material. In particular, the sheet may be a non-woven material formed from spun bond olefin fibre such as Tyvek (RTM). Such a material is very thin and flexible but durable and tear resistant. In the first embodiment, the applicator 30 comprises an elongate strip 32 with a plurality of fingers 34 projecting from one side of the strip 32. In this example, four equally spaced fingers 34 are provided. Preferably the fingers 34 are perpendicular to the elongate strip 32. A proximal portion 36 of each finger 34 which is adjacent to the elongate strip 32 may be formed with parallel edges 36a. A distal portion 38 of each finger 34 which is spaced from the elongate strip 32 may be tapered and gets narrower towards the tip 40. However, the precise shape and positioning of the fingers 34 may vary. In use, the elongate strip 32 is folded round into a generally arcuate shape to define an enclosure 42 and the fingers 34 are folded over towards one another as shown in Figures 3 and 4. As best seen in the plan view of Figure 4, the arcuate strip 32 may extend around approximately 270°. In this position, the fingers 34 are at approximately 90° to each other. Due to the width of the fingers 34, the strip 32 may not form a completely circular arc and portions of the strip 32 which are adjacent to the fingers 34 may remain substantially straight with the remaining portions of the strip 32 in between the fingers 34 being curved. The proximal portions 36 of the fingers 34 extend substantially upwardly from the strip 32. The distal portions 38 of the fingers 34 are folded over towards each other and at more than 90° relative to the proximal portions 36, so that the distal tips 40 of the fingers 34 extend down towards the centre of the enclosure 42 defined by the arcuate strip 32. In use, as shown in Figure 6, the applicator 30 in its folded form is placed with the arcuate strip 32 encircling the cylindrical body 12 of an accessory 10. The straight proximal portions 36 of the fingers 34 extend upwardly adjacent to the exterior of the cylindrical body 12 and past the second end 16 thereof. The distal portions 38 of the fingers 34 are folded over the second end 16 of the cylindrical body 12 and extend down into the bore 18 of the cylindrical body 12. As shown in Figures 7 and 8, distal portions 38 of the fingers 34 thus define four guide surfaces 44 extending down into the bore 18 of the cylindrical body 12. In combination, these guide surfaces 44 provide a tapering guide channel 46 for receiving the distal end of a shaft 50 of a medical device. Insertion of the shaft 50 is illustrated in Figures 9-13. The distal tip of the shaft 50 is pushed into the tapering guide channel 46 defined by the guide surfaces 44 of the folded-over fingers 34, as shown in Figure 9. As the shaft 50 is inserted further, it pushes the fingers 34 radially outwardly towards the interior surface of the bore 18 of the cylindrical body 12, as shown in Figure 10. Once the shaft 50 is inserted a substantial amount, for example at least halfway into the accessory 10, the applicator 30 can be removed. The strip 32 and proximal portions 36 of the fingers 34 may be folded upwardly so that they are clear of the accessory 10, as shown in Figure 11. The strip 32 and fingers 34 can then pulled up and to one side in order to withdraw the distal portions 38 of the fingers 34 from between the shaft 50 and the interior surface of the cylindrical body 12, as shown in Figure 12. The applicator 30 can then be removed entirely, leaving the accessory 10 in position around the distal tip of the shaft 50, as shown in Figure 13. If necessary, the accessory 10 can be pushed by a user’s finger further on to the shaft 50 so that the shaft 50 extends fully into the bore 12 as far as the first end 14. The configuration of the applicator 30 can be varied from that discussed above and some possible examples are illustrated in Figures 14-17. In Figure 14a, another example applicator 60 is shown in plan and perspective views. The applicator 60 comprises a thin flexible sheet shaped to provide a pair of elongate panels 62. Each panel 62 is generally rectangular with an opposing pair of short edges and an opposing pair of long edges. The panels 62 are joined by a flexible connecting element 64 extending laterally from one long edge of one panel 62 to a long edge of the other panel 62. In this example, the flexible connecting element 64 is at approximately the midpoint of the long edges, so that the applicator 60 is substantially H-shaped and has a longitudinal axis X. The panels 62 can be folded towards one another by bending the flexible connecting element 64 and each panel 62 can be curved into an arcuate shape around the longitudinal axis X to form a generally cylindrical, or slightly frusto-conical shape. In this form, the applicator 60 can be partially inserted into the bore 18 of the cylindrical body 12 of an accessory 10 to provide a guide channel 66 as seen in Figure 14b. In Figure 15a, another example applicator 70 is shown in plan and perspective views. The applicator 70 also comprises a thin flexible sheet shaped to provide a pair of elongate panels 72 joined by a flexible connecting element 74. In this case, the flexible connecting element 74 joins the two elongate panels 72 at one end so that the applicator 70 is substantially U-shaped. As with the examples of Figures 14a and 14b, the panels 72 can be folded towards each other by bending the flexible connecting element 74 and curved into an arcuate shape about the longitudinal axis X to form a generally cylindrical, or slightly frusto-conical shape. In this form the applicator 70 can be partially inserted into the bore 18 of the cylindrical body 12 of an accessory 10 to provide a guide channel 76 as seen in Figure 15b. In Figure 16a, another example applicator 80 is shown in plan and perspective views. The applicator 80 comprises two separate elongate panels 82 which are substantially rectangular and are not connected to each other. Each panel 82 is formed from a thin flexible sheet and can be bent into an arc around its longitudinal axis X so that it forms a substantially semi-cylindrical shape. The two panels 82 can then be partially inserted facing each other into the bore 18 of the cylindrical body 12 of an accessory 10 to provide a guide channel 84 as shown in Figure 16b. Figures 17a-d show another example applicator 90 which comprises a thin flexible sheet 92 which is substantially square or rectangular. A tab 94 preferably extends from one edge of the sheet 92. The sheet 92 can be folded round into a generally cylindrical or frusto-conical form, with the tab 94 uppermost, as shown in Figure 17b. In this form the applicator 90 can be partially inserted into the bore 18 of the cylindrical body 12 of an accessory 10 to provide a guide channel 96 for the shaft 50, as shown in Figure 17c. Once the shaft 50 has been inserted, the tab 94 can be gripped by a user and use to remove the applicator 90 as shown in Figure 17d. In each case, the thin, flexible material of the applicator 30, 60, 70, 80, 90 can be deformed from a flat sheet (or sheets) to create a sleeve which fits within the bore 18 of the cylindrical body 12 to stabilise it and to define a guide channel to aid insertion of the shaft 50 into the accessory 10. In the embodiments of Figures 14-16, each elongate panel may be dimensioned such that its length is about twice the length of the cylindrical body 12 of the accessory 10, so that the panels extend a significant distance out of the accessory 10 for ease of removal. The width of each panel may be about half of the circumference of the bore 18 of the cylindrical body 12. For the example applicator 90 shown in Figure 17, the height of the panel 92 may be about twice the length of the cylindrical body 12 of the accessory 10. The width of the panel 92 may be about the same or slightly greater than the circumference of the bore 18. Figures 18-22 illustrate an alternative device to assist with installation of an accessory 10 on to a shaft 50 of a medical device. It comprises essentially a holder with a base and an upwardly projecting column, over which the cylindrical body of an accessory can be seated. In the example illustrated, the device comprises a container 100 in which an accessory 10 may be stored prior to use. The container 100 may be generally cylindrical and comprises a flat circular base 102 and a cylindrical side wall 104. One or more sloping walls may be provided between the base 102 and the side wall 104. In this example a first, steeper sloping wall 106a is provided around the flat base wall 102 and a shallower sloping wall 106b is provided between the steeper sloping wall 106a and the side wall 104. An annular lip 108 extends around the upper edge of the side wall 104. In use, a peel-off cover (not shown) for the container 100 may be adhered to the lip 108. Within the container 100, a central column 110 projects upwardly from the base wall 102. The upper surface 112 of the column 110 slopes from one side to the other relative to the base wall 102, as shown in section A-A of Figure 18. In use, as shown in Figure 19, an accessory 10 fits within the container 100, with the cylindrical body 12 seated over the column 110. The first end 14 of the accessory 10 sits within the recess created by the steeper sloping wall 106a. The projecting arms 20 are supported on the shallower sloping wall 106b as shown in section B-B of Figure 19. The cylindrical body 12 extends above the top of the column 110. The lowermost side of the sloping upper surface 112 may be slightly less than halfway up the length of the body 12 whilst the uppermost side of the upper sloping surface 112 may be slightly more than halfway up the cylindrical body 12. The accessory 10 may be stored in a sterile condition in the container 100 with a cover (not shown) across the open top of the container 100 and adhered to the lip 108 to seal the container 100. When the accessory 10 is required for use, the cover is removed. As shown in Figure 20, the distal end of a shaft 50 of a medical device is inserted into the cylindrical body 12 until the end face of the shaft 50 abuts the sloping upper surface 112 of the column 110. Due to the slope, the shaft 50 is therefore at a slight angle to the vertical as shown in Figure 20 and the elastic wall of the cylindrical body 12 is slightly deformed. Nevertheless, the column 110 stabilises the cylindrical body 12 and prevents it being folded or crumpled up as the shaft 50 is inserted. The cylindrical body 12 is dimensioned to grip the shaft 50. However, a user’s finger F may be pressed against the side of the cylindrical body 12 as shown in Figure 21 to keep it in contact with the shaft 50 as the shaft 50 is withdrawn from the container 100, bringing the accessory 10 with it. Once clear of the column 110, the finger F can be removed leaving the accessory 10 gripping the shaft 50 as shown in Figure 22. The container 100 can then be disposed of. A holder such as the container 100, with the column 110 and sloping upper surface 112, may be used alone to store an accessory 10 and to facilitate fitting the accessory 10 onto a shaft 50 when required. However, the container 10 may also be used in conjunction with an applicator device of any of the embodiments described above. For example, the applicator may be fitted within an upper region of the bore 18 of the cylindrical body 12, while the lower portion of the body 12 is supported by the column 110. The material of the applicator device is sufficiently thin that, if necessary, it may also be inserted further into the cylindrical body 12, between the column 110 and the inner surface of the bore 18. Thus, the present disclosure provides applicator devices to facilitate fitting a tubular accessory onto the distal end of the shaft of a medical device. This ensures the accessory is fitted efficiently and correctly so that it grips the shaft and will not become dislodged in use. As noted above, in this disclosure the term “medical device” may refer to an endoscope, but this term is also intended to refer to any device suitable for insertion into a biological cavity or lumen in order to carry out visualisation thereof and / or treatment. Accordingly, the term “medical device” is intended to encompass any or all of endoscopes, gastroscopes, 5 colonoscopes, enteroscopes, sigmoidoscopes, panendoscopes, but this list is non-exhaustive. Endoscopy involves inspecting the inside of a body lumen or cavity and includes procedures known as arthroscopy, cystoscopy, gastroscopy, uteroscopy and colonoscopy. Enteroscopy involves examination of the small intestine including the duodenum, jejunum and ileum. Such devices are elongate flexible probes which may be 10 inserted into the body directly or via a cannula or other guide device. Medical devices can also include rigid surgical endoscopes or endotherapy devices such as biopsy forceps and polypectomy snares. The cover of the present disclosure may be used in conjunction with all of the aforementioned types of medical device.

Claims

1. An applicator for fitting a tubular cover over a distal end of a shaft of a medical device, the applicator comprising a thin, flexible sheet which is deformable into an arcuate shape, wherein at least part of the applicator is insertable into a bore defined by a tubular cover such that the applicator defines a guide channel for receiving a distal end of a shaft of a medical device.

2. An applicator as claimed in claim 1, wherein the applicator comprises an elongate element and a plurality of fingers extending laterally from one side of the elongate element, wherein the elongate element is formable into an arc defining an enclosure and the fingers are foldable so as to extend into the enclosure, and wherein the fingers define the guide channel.

3. An applicator as claimed in 2, wherein each finger comprises a proximal portion adjacent to the elongate element and a distal portion spaced from the elongate element and wherein the distal portion is foldable so as to extend into the enclosure.

4. An applicator as claimed in claim 3, wherein the distal portion of each finger is tapered.

5. An applicator as claimed in claim 2 or claim 3, wherein the applicator comprises four fingers.

6. An applicator as claimed in claim 5, wherein the elongate element is deformable into an arc extending around approximately 270° such that the fingers are at approximately 90° to each other.

7. An applicator as claimed in claim 1, wherein the applicator comprises first and second elongate panels, wherein each elongate element has a longitudinal axis and is deformable into an arcuate shape around the longitudinal axis.

8. An applicator as claimed in claim 7, wherein the elongate elements are joined to one another by a flexible connecting element transverse to the longitudinal axis and extending laterally from an edge of the first elongate element to an edge of the second elongate element.

9. An applicator as claimed in claim 8, wherein the flexible connecting element is located midway between first and second ends of each elongate element, such that the applicator is H-shaped.

10. An applicator as claimed in claim 8, wherein the flexible connecting element is located adjacent to a first end of each elongate element, such that the applicator is substantially U-shaped.

11. An applicator as claimed in claim 1, comprising a substantially square or rectangular sheet with a tab projecting from one edge thereof.

12. A method for fitting a tubular cover to a shaft of a medical device using an applicator as claimed in any preceding claim, the method comprising the steps of forming at least part of the applicator into an arcuate shape, inserting at least part of the applicator into a bore defined by the tubular cover, to form a guide channel, inserting a shaft of a medical device into the guide channel and removing the applicator from between the shaft and the cover to leave the cover in position on the shaft.

13. A method for fitting a tubular cover to a shaft of a medical device using an applicator as claimed in claim 12, when dependent on any of claims 2-6, wherein the method comprises forming the elongate element into an arcuate shape defining an enclosure, fitting the elongate element around the exterior of a tubular cover such that the cover is within the enclosure, folding the fingers towards one another and into the enclosure such that they extend over an end of the tubular cover and into a bore defined by the tubular cover to create a guide channel, inserting the shaft of a medical device into the guide channel, and removing the fingers from between the shaft and the cover to leave the cover in position on the shaft.

14. An applicator as claimed in any of claims 1-11, in combination with a holder for a tubular cover for fitting over a distal end of a shaft of a medical device, the holder comprising a base and a column projecting from the base and dimensioned to fit within a bore defined by the tubular cover, the column having an upper surface which is sloping with respect to the base, wherein a tubular cover is locatable over the column and the applicator is insertable into the bore of the tubular cover.

15. A holder for a tubular cover for fitting over a distal end of a shaft of a medical device, the holder comprising a base and a column projecting from the base and dimensioned to fit within a bore defined by the tubular cover, the column having an upper surface which is sloping with respect to the base.

16. A holder as claimed in claim 15, wherein the holder further comprises a side wall surrounding the base and the base and side wall form a container for storing the tubular cover.

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